The European Commission published on 26 July a number of non-papers on practical solutions proposed to the UK government on 30 June to facilitate the implementation of the Protocol on Ireland/Northern Ireland and (see EUROPE 12752/19).
While the UK government called for a renegotiation of the protocol last week, the two documents set out the proposed solution in the areas of medicines and sanitary and phytosanitary measures, the institution said in a statement.
One paper focuses on how to “undisrupted supply of medicines to Northern Ireland [...] from or through Great Britain”.
The Commission recalls that it has proposed, for example, that “[r]egulatory compliance functions may exceptionally be located in the UK in respect of medicines covered by any national authorisations issued by the UK authorities in respect of Northern Ireland” provided that London “fully applies the relevant Union legislation on medicines: on quality, safety, efficacy, pharmacovigilance and batch testing and release when issuing national marketing authorisations in respect to Northern Ireland [and] the marketing authorisation contains a legal prohibition of sale (resale) outside its geographical scope”.
It also requests that the UK’s competent authorities strengthen their control to monitor compliance with these requirements.
Another document outlines the measures the institution has proposed for guide dogs or the transport of live animals between Great Britain and Northern Ireland, for example for fairs.
“These solutions have one clear common denominator: they have been made with the essential aim of benefiting the people of Northern Ireland”, Vice President Maroš Šefčovič commented in the statement, adding that the solution on medicines “involves the EU changing its own rules”. A legislative proposal on this subject is expected in early autumn, he said.
Link to documents: https://bit.ly/3i3hPgQ (Original version in French by Solenn Paulic)